Liver Dose Adjustments

Precautions

During the marketing of desloratadine, the following spontaneous adverse events have been reported: tachycardia, elevated liver enzymes including bilirubin and rarely hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis).

An increase in the incidence of somnolence has been reported in clinical trials (n=1838) at doses of 10 mg/day and 20 mg/day (5.2% and 7.6%, respectively), compared to placebo (2.3%).

A small sector of the general population (not prospectively identified) is unable to form 3-hydroxydesloratadine, resulting in up to 6 fold increase in AUC and half-life of over 50 hours. In pharmacokinetic studies (n=276). approximately 20% of blacks were slow metabolizers.

Dialysis

Desloratadine and its main active metabolite, 3-hydroxydesloratadine, are not removed by hemodialysis.

There are no data on the safe use of desloratadine in patients undergoing peritoneal dialysis.

Other Comments

Disintegrating tablet must be used immediately after opening the blister.